The Active Implantable Medical Device (AIMD) Directive 90/385/EEC defines an active implantable medical device as “any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.” As one of the highest risk categories of device, active implantable medical devices (AIMDs) are subject to rigorous regulatory controls during both pre-market and post-market periods. The regulatory controls set out in the AIMD Directive also apply to all accessories that are used to enable the device to operate as intended, for example, leads, programmers, controllers, battery packs, software applications, implant kits and refill kits.
Examples of AIMDs may include implantable cardiac pacemakers, implantable defibrillators, left ventricular assist device, leads, electrodes, adaptors for implantable cardiac pacemakers and defibrillators, brachytherapy, haemodynamic support, cochlear implants, implantable infusion pumps and accessories, implantable glucose monitors, micro electro-mechanical systems (MEMS), implantable gastric stimulator, neuroprosthetics, transcutaneous vagus nerve stimulation, insulin pumps, neurostimulators, various drug delivery systems, and others. The devices may be used to treat chronic ailments such as cardiac arrhythmia, diabetes, and Parkinson's disease. Many AIMDs are enabled with wireless communication capabilities and can communicate with an external device. With the rise in use of AIMDs, however, security becomes a critical issue, as attacks on AIMDs may harm the patient wearing the device.